Drug Development Program Started Based on CAP® Human Cell Line
News Mar 04, 2009
Alloksys Life Sciences BV, CEVEC Pharmaceuticals GmbH and PharmaCell BV announce the start of Theraptech, a 2.4 million Euro therapeutic protein development program subsidized under the European Trans Bio Program.
The major objective of the Theraptech project is to develop a recombinant human alkaline phosphatase (rhuAP) using the novel versatile human CAP® cell line, which has been shown to efficiently express glycosylated proteins. The rhuAP produced in CAP® cells is expected to feature improved pharmacokinetic and safety profile allowing for repeated dosing of alkaline phosphatase in chronic diseases.
Based on a the anti-inflammatory mechanism of action of alkaline phosphatase towards e.g. TNFa, IL-6 and IL-8, as shown in both pre-clinical and clinical studies in acute conditions, we propose it to be developed as a therapeutic protein in major chronic diseases such as Rheumatoid Arthritis.
The combined expertise of the members participating in the consortium covers the entire spectrum of activities needed to drive the project from molecular biology to GMP-production and recombinant product testing in preclinical and clinical trials, pushing towards a clinical phase II compliant product within the 3-year-time frame of the project.
Commenting on this unique co-operation, PharmaCell’s CEO, Maurice Horsten, commented “Combining the strengths of our companies provides us with an excellent opportunity to build on PharmaCell’s motto Humanizing Medicine® and to push this important project forward to the benefit of many patients around the world”.
Cevec’s CEO Dr Rainer Lichtenberger added: “CEVEC is excited about the strong scientific and commercial prospects of the Theraptech project. rhuAP will turn out to perfectly demonstrate the unique strengths of CEVEC’s proprietary CAP® cell expression technology, in combination with the proven capabilities of our partners “.
On the scientific importance Alloksys’ COO, Dr Ruud Brands commented, ”rhuALP, based on the proposed mechanism of action in innate immune modulation, may enable the application in a wide array of disabling chronic inflammatory conditions, thereby eliminating the potentially adverse effects of currently marketed blockbuster products.”